Role Summary
As an Electrophoresis Subject Matter Expert within AbbVie's Analytical Development team for Targeted LNP (tLNP) CMC, you will lead development, optimization, and qualification of electrophoresis-based methods that measure the mRNA and tLNP. You will collaborate with global Analytical CMC and R&D partners to build and deploy analytical tools for quality, safety, and integrity of tLNP medicines. The role requires hands-on method development experience with electrophoresis techniques (CE, cIEF, CZE) and a proven ability to transfer methods across teams and labs.
Responsibilities
- Function as an SME for Electrophoresis methods, generating original technical ideas and research or development strategies.
- Develop and optimize CE-LIF for assessing mRNA purity, qualify the methods for phase-appropriate use.
- Explore the potential of different electrophoresis methods to analyze mRNA-LNP size, degradation, purity and encapsulation efficiency.
- Lead tech transfer, implementation and lifecycle management of Electrophoresis related methods (e.g., CE, icIEF, CZE).
- Generate new scientific proposals and lead those efforts.
- Demonstrated ability to collaborate effectively with team members and a willingness to continuously learn new techniques to enhance and advance the analytical capabilities of the program.
- Demonstrate scientific initiative and creativity in research or development activities and maintain a high level of productivity in the lab.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.
- Understand and comply with AbbVie safety, quality and regulatory policies and government regulations.
Qualifications
- Scientist II: Analytical Chemistry degree (or related field). BS with 7+ years', MS with 5+ years' industry experience.
- Senior Scientist I: Analytical Chemistry degree (or related field). BS with 10+ years', MS with 8+ years', and PhD with 0+ years' industry experience.
- Deep understanding of the Electrophoresis principle, familiar with PA800+ / BioPhase 8800 / Maurice instruments and have hands on experience on at least one of these three instruments.
- Understand the effects of key variables on method performance and utilize DOE approaches to achieve robust method development.
- Direct experience developing, qualifying, and transferring Electrophoresis related methods for at least one of the following modalities: mRNA, antibody, LNP.
- Ability to coordinate and help troubleshoot Electrophoresis analysis work at external CDMOs or contract testing labs.
- Hands-on experience with additional analytical techniques relevant to mRNA or LNP analysis is considered a plus.
- Working knowledge of biosafety, data integrity, and compliance requirements for GxP-regulated testing.
- Strong presentation and communication skills with the ability to explain data to technical and non-technical audiences.